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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.; BIPOLAR ELECTRODE
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KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.; BIPOLAR ELECTRODE Back to Search Results
Model Number 27040GP130-S
Device Problem Overheating of Device (1437)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device evaluation confirmed one of the electrodes separated and is missing; the insulation on distal end melted.
 
Event Description
Allegedly, during a urology procedure, two bipolar electrode broke and pieces fell into patient.The broken pieces were retrieved, and customer confirmed there was no harm to patient.This report is for the first electrode that broke.
 
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Brand Name
CUTTING LOOP, BIPOLAR, 0.30MM, 24/26 FR.
Type of Device
BIPOLAR ELECTRODE
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM 
Manufacturer (Section G)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
78532
tuttlingen,
GM  
Manufacturer Contact
susie chen
2151 e. grand avenue
el segundo, CA 90245-5017
4242188201
MDR Report Key10909737
MDR Text Key219137842
Report Number9610617-2020-00134
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551393864
UDI-Public4048551393864
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27040GP130-S
Device Catalogue Number27040GP130-S
Device Lot Number37CJ2529
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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